Not yet recruitingOBSERVATIONAL

The Inflammatory Profile of Exacerbations in Patients With Severe Asthma Receiving Tezepelumab: The TezEx Study

This study, called 'TezEx', is looking at people with severe asthma who are taking a new medicine called tezepelumab. Tezepelumab is a treatment approved in the UK for severe asthma when other medications haven't been enough. Even with this new medicine, some patients still experience asthma flare-ups, which can be very serious. The main goal of this research is to understand the body's natural responses and why these flare-ups still happen in some individuals. By carefully studying patients' health information both from the past and as they continue their treatment, researchers hope to gain insight into how to better manage severe asthma and reduce the number of flare-ups, ultimately improving the quality of life for these patients.

At a glance

Status

Not yet recruiting

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrolment target

150

Start

01 Dec 2024

Estimated completion

30 Jun 2026

Severe Asthma

What is this study about?

Asthma is a common lung condition that makes it hard to breathe sometimes. Symptoms like wheezing, feeling short of breath, chest tightness, and coughing can come and go. For a small group of people, asthma is very severe. This means their symptoms are tough to control, even with strong inhalers. These individuals often have serious flare-ups, need hospital visits, and their daily lives are greatly affected.

A new medicine called tezepelumab has been approved in the UK for people with severe asthma. It works by targeting a specific natural alarm signal in the body, called TSLP, that kick-starts inflammation – the body's way of reacting to irritation or injury. By blocking this signal, tezepelumab aims to calm down the severe reaction that causes asthma symptoms and flare-ups.

However, even with tezepelumab, some people with severe asthma still get flare-ups. This study, called 'TezEx', wants to find out why. By looking closely at information from patients – both from their past medical records and during their ongoing treatment – the researchers hope to understand more about the body's natural inflammatory responses in these situations. The aim is to learn how to make treatments even better in the future, helping to reduce flare-ups and improve life for people with severe asthma.

Key takeaways

This study focuses on understanding severe asthma patients treated with tezepelumab.
The main goal is to find out why some patients still get asthma flare-ups.
It uses existing medical information and checks during flare-ups.
The findings could lead to better severe asthma treatments in the future.
Participation involves no new medicines, only observation and data collection.
You can stop participating at any time without affecting your health care.

Who may be eligible?

To be part of this study, you need to be an adult between 18 and 80 years old.

You should either be about to start tezepelumab treatment for your severe asthma, or you should have started it fairly recently – within the last 36 weeks (about 9 months). You also need to meet the specific health criteria set by NICE (the National Institute for Health and Care Excellence) for receiving tezepelumab and be receiving your care at Guy's severe asthma centre.

There are also some reasons why you might not be able to join. For example, if you have other serious medical conditions that might affect your asthma treatment or your ability to take part, or a history of drug or alcohol abuse. Also, if you have other severe lung conditions like certain types of eosinophilic lung disease, severe bronchiectasis causing daily phlegm, or are on long-term antibiotics like azithromycin or doxycycline, you might not be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 80 years old?
Are you about to start tezepelumab, or have you started it within the last 9 months?
Are you being treated for severe asthma at Guy's severe asthma centre?
Do you meet the NICE criteria for tezepelumab treatment?
Do you not have other serious lung conditions like severe bronchiectasis or certain eosinophilic diseases?
Are you not currently on long-term antibiotics like azithromycin or doxycycline for your lungs?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the researchers will collect information about your health. Much of this will come from your regular medical records. You'll also be asked to come in for extra checks if you have a significant worsening of your asthma symptoms. The study doesn't involve any new medication beyond your standard tezepelumab treatment and regular asthma medicines. The total duration of your participation will depend on when you start the study in relation to your tezepelumab treatment, but it will be within the usual follow-up period for patients on this medication.

Potential risks and benefits

Taking part in this study might not directly benefit your health, but the information collected could help doctors understand severe asthma better and improve future treatments for others. Your participation will involve sharing your medical information, and if you have a flare-up, you might need to come in for extra assessments. There are no direct medical risks from the study itself, as you'll be receiving your usual care. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Guys & St Thomas NHS Foundation Trust
Verified postcode
London, United Kingdom

Common questions

What is tezepelumab?

Tezepelumab is a special medicine approved for people with severe asthma that's hard to control, even with strong inhalers. It helps calm down the body's exaggerated reactions that cause asthma symptoms.

What is a 'flare-up' or 'exacerbation'?

An asthma flare-up is when your asthma symptoms突然get much worse, like severe shortness of breath or wheezing. It often means you need extra medicine or even a hospital visit.

Will I have to take any new medicines for this study?

No, you will not be given any new or different medicines as part of this study. You will continue to take your regular asthma medications, including tezepelumab, as prescribed by your doctor.

How long will I be in the study?

The study will look at your information over a period that aligns with your tezepelumab treatment, starting from around when you began the treatment or are due to start it. The exact length will be discussed with you.

Will my regular asthma treatment be affected?

No, your regular asthma treatment and care will not be affected by you taking part in this study. You will continue to receive the care your doctors recommend.

How to find out more

Mathew Clinical Trial Coordinator, MSc

mathew.furtado@gstt.nhs.uk +44 207 188 7188 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.